Brief Description of Focus of StudyPhase 2NCT06912165
A Study of WD-890 in Participants With Moderate-to-Severe Plaque Psoriasis
A Phase 2 study testing WD-890 tablet in people with Brief Description of Focus of Study, run by Zhejiang Wenda Pharma Technology LTD. at 1 site in China.
Trial summary
Th purpose of the study is to evaluate the dose response of WD-890 in efficacy at Week 16 in participants with moderate-to-severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Brief Description of Focus of Study
- What is being tested?
- WD-890 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2024to 30 Nov 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participant aged 18 to 70 years(inclusive)at the time of informed consent.
- Diagnosis of plaque psoriasis for at least 6 months prior to the screening visit.
- ≥10% of BSA involvement at screening visit and randomization;
- Psoriasis Area and Severity Index (PASI) score ≥12 and static Physician's Global Assessment (sPGA) ≥3 at screening visit and randomization
Who cannot join
- Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, inverse, pustular,or drug induced psoriasis.)
- Has uncontrolled arterial hypertension characterized by a systolic blood pressure (BP) ≥160 mm Hg or diastolic BP ≥100 mm Hg Note: Determined by 2 consecutive elevated readings. If an initial BP reading exceeds this limit, the BP may be repeated once after the subject has rested sitting for ≥10 minutes. If the repeat value is less than the criterion limits, the second value may be accepted
- Class III or IV congestive heart failure by New York Heart Association Criteria
- Participant with a history of chronic bacterial infections (e.g., chronic pyelonephritis, chronic bronchiectasis, or chronic osteomyelitis).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College
Nanjing, Jiangsu, 210000
Qianjin Lu, doctor, +86 13787097676, qianlu5860@pumcderm.cams.cn
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of WD-890 Tablets for the Treatment of Moderate to Severe Plaque Psoriasis
Th purpose of the study is to evaluate the dose response of WD-890 in efficacy at Week 16 in participants with moderate-to-severe plaque psoriasis.
Read the detailed description
The total duration of this study is up to 24 weeks which includes a screening period of less than or equal to (<=) 4 weeks, a 16-week treatment period, and a 4-week safety follow-up period. Aged 18 to 70 years (inclusive) were enrolled in this study. Participants were randomized to receive WD-890 or placebo.
- Conditions
- Brief Description of Focus of Study
- Being tested
- WD-890 tablet, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WD-890 tabletDrug
Participants will receive WD-890 Dose 1 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
WD-890 tabletDrug
Participants will receive WD-890 Dose 2 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
WD-890 tabletDrug
Participants will receive WD-890 Dose 3 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
PlaceboDrug
Participants will receive placebo QD from Week 0 through Week 16.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: WD-890 Dose 1 QD and Placebo | Experimental | Not described Receives: Drug: WD-890 tablet |
| Group 2: WD-890 Dose 2 QD and Placebo | Experimental | Not described Receives: Drug: WD-890 tablet |
| Group 3: WD-890 Dose 3 QD and Placebo | Experimental | Not described Receives: Drug: WD-890 tablet |
| Group 4: Placebo | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16
Measured: Screening up to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start31 Dec 2024
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brief Description of Focus of StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Wenda Pharma Technology LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912165
- Sponsor's protocol ID
- WENDA890PSO-001
- Status last verified
- Mar 2025
- First submitted
- 28 Mar 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of WD-890 Tablets for the Treatment of Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT06912165
- Acronym / sponsor ID
- WENDA890PSO-001
- Conditions
- Brief Description of Focus of Study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Zhejiang Wenda Pharma Technology LTD.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Th purpose of the study is to evaluate the dose response of WD-890 in efficacy at Week 16 in participants with moderate-to-severe plaque psoriasis.
Detailed description
The total duration of this study is up to 24 weeks which includes a screening period of less than or equal to (<=) 4 weeks, a 16-week treatment period, and a 4-week safety follow-up period. Aged 18 to 70 years (inclusive) were enrolled in this study. Participants were randomized to receive WD-890 or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: WD-890 Dose 1 QD and Placebo | Experimental | Drug: WD-890 tablet |
| Group 2: WD-890 Dose 2 QD and Placebo | Experimental | Drug: WD-890 tablet |
| Group 3: WD-890 Dose 3 QD and Placebo | Experimental | Drug: WD-890 tablet |
| Group 4: Placebo | Experimental | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female participant aged 18 to 70 years(inclusive)at the time of informed consent.
- Diagnosis of plaque psoriasis for at least 6 months prior to the screening visit.
- ≥10% of BSA involvement at screening visit and randomization;
- Psoriasis Area and Severity Index (PASI) score ≥12 and static Physician's Global Assessment (sPGA) ≥3 at screening visit and randomization
Key exclusion criteria (4 listed)
- Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, inverse, pustular,or drug induced psoriasis.)
- Has uncontrolled arterial hypertension characterized by a systolic blood pressure (BP) ≥160 mm Hg or diastolic BP ≥100 mm Hg Note: Determined by 2 consecutive elevated readings. If an initial BP reading exceeds this limit, the BP may be repeated once after the subject has rested sitting for ≥10 minutes. If the repeat value is less than the criterion limits, the second value may be accepted
- Class III or IV congestive heart failure by New York Heart Association Criteria
- Participant with a history of chronic bacterial infections (e.g., chronic pyelonephritis, chronic bronchiectasis, or chronic osteomyelitis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WD-890 tabletParticipants will receive WD-890 Dose 1 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens. | Drug | Group 1: WD-890 Dose 1 QD and Placebo |
| WD-890 tabletParticipants will receive WD-890 Dose 2 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens. | Drug | Group 2: WD-890 Dose 2 QD and Placebo |
| WD-890 tabletParticipants will receive WD-890 Dose 3 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens. | Drug | Group 3: WD-890 Dose 3 QD and Placebo |
| PlaceboParticipants will receive placebo QD from Week 0 through Week 16. | Drug | Group 4: Placebo |
Primary outcome
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16
Time frame: Screening up to Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WD-890 tablet in people with Brief Description of Focus of Study, run by Zhejiang Wenda Pharma Technology LTD. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qianjin Lu, doctor (+86 137 8709 7676, qianlu5860@pumcderm.cams.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16 (time frame: Screening up to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.